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Post-resection Treatment of Large Colon Polyps

NCT03654209 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 384

Last updated 2024-01-05

Study results available
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Summary

Patients who have provided informed consented and are scheduled to undergo endoscopic mucosal resection (EMR) of lesions 15mm and larger will be randomized to STSC (80 W, Effect 5) vs APC (preferred settings) vs No Treatment of the perimeter of the EMR site.

Conditions

  • Recurrence

Interventions

DEVICE

Argon Plasma Coagulation

APC will be applied to the perimeter of the resection site

DEVICE

Snare Tip Soft Coagulation

STSC will be applied to the perimeter of the resection site

Sponsors & Collaborators

  • Erbe USA Incorporated

    collaborator OTHER

  • Indiana University

    lead OTHER

Principal Investigators

  • Douglas K. Rex, MD · Indiana University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
25 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-10-16
Primary Completion
2022-12-14
Completion
2022-12-14
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03654209 on ClinicalTrials.gov